BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II EZ

    MDR report key: 1041549 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31994
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    October 8, 2007
    Report Date
    March 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II EZ IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4469 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other THE DEVICE 0157/130991 WAS IMPLANTED 18-NOV-2005| THE DEVICE 4517/419560 WAS IMPLANTED 18-NOV-2005| THE DEVICE 6481 045546 WAS USED DURING THE EVENT.| THE DEVICE H179/110921 WAS IMPLANTED 18-NOV-2005